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In vitro dose characterization studies were performed to evaluate the delivery of VENTOLIN HFA via holding chambers with attached masksThe studies were conducted with 2 different holding chambers with maskssmall and medium sizeThe in vitro study data when simulating patient breathing suggest that the dose of VENTOLIN HFA presented for inhalation via a valved holding chamber with mask will be comparable to the dose delivered in adults without a spacer and mask per kilogram of body weightTable 2Howeverclinical trials in children younger than 4 years described above suggest that either the optimal dose of VENTOLIN HFA has not been defined in this age-group or VENTOLIN HFA is not effective in this age-groupThe safety and effectiveness of VENTOLIN HFA administered with or without a spacer device in children younger than 4 years have not been demonstrated.

In vitro dose characterization studies were performed to evaluate the delivery of VENTOLIN HFA via holding chambers with attached masksThe studies were conducted with 2 different holding chambers with maskssmall and medium sizeThe in vitro study data when simulating patient breathing suggest that the dose of VENTOLIN HFA presented for inhalationvia a valved holding chamber with mask will be comparable to the dose delivered in adults without a spacer and mask per kilogram of body weightTable 2Howeverclinical trials in children younger than 4 years described above suggest that either the optimal dose of VENTOLIN HFA has not been defined in this age-group or VENTOLIN HFA is not effective in this age-groupThe safety and effectiveness of VENTOLIN HFA administered with or without a spacer device in children younger than 4 years have not been demonstrated.

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table 1 lists the incidence of all adverse reactions whether considered by the investigator to be related or unrelated to drug from these trials that occurred at a rate of 3 or greater in the group treated with ventolin hfa and more frequently in the group treated with ventolin hfa than in the hfa-134a placebo inhaler group.